EP2214643A4 - Transdermal delivery system for hormones and steroids - Google Patents

Transdermal delivery system for hormones and steroids

Info

Publication number
EP2214643A4
EP2214643A4 EP08845547A EP08845547A EP2214643A4 EP 2214643 A4 EP2214643 A4 EP 2214643A4 EP 08845547 A EP08845547 A EP 08845547A EP 08845547 A EP08845547 A EP 08845547A EP 2214643 A4 EP2214643 A4 EP 2214643A4
Authority
EP
European Patent Office
Prior art keywords
steroids
hormones
delivery system
transdermal delivery
transdermal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP08845547A
Other languages
German (de)
French (fr)
Other versions
EP2214643B1 (en
EP2214643A1 (en
Inventor
Kerrie Setiawan
Adam Watkinson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Acrux DDS Pty Ltd
Original Assignee
Acrux DDS Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Acrux DDS Pty Ltd filed Critical Acrux DDS Pty Ltd
Priority to PL08845547T priority Critical patent/PL2214643T3/en
Publication of EP2214643A1 publication Critical patent/EP2214643A1/en
Publication of EP2214643A4 publication Critical patent/EP2214643A4/en
Application granted granted Critical
Publication of EP2214643B1 publication Critical patent/EP2214643B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00Devices for applying media, e.g. remedies, on the human body
    • A61M35/003Portable hand-held applicators having means for dispensing or spreading integral media
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10Drugs for genital or sexual disorders; Contraceptives for impotence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/16Masculine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26Androgens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30Oestrogens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
EP08845547.2A 2007-11-02 2008-10-31 Transdermal delivery system for hormones and steroids Not-in-force EP2214643B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL08845547T PL2214643T3 (en) 2007-11-02 2008-10-31 Transdermal delivery system for hormones and steroids

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US98478707P 2007-11-02 2007-11-02
PCT/AU2008/001613 WO2009055859A1 (en) 2007-11-02 2008-10-31 Transdermal delivery system for hormones and steroids

Publications (3)

Publication Number Publication Date
EP2214643A1 EP2214643A1 (en) 2010-08-11
EP2214643A4 true EP2214643A4 (en) 2010-12-01
EP2214643B1 EP2214643B1 (en) 2014-04-02

Family

ID=40590452

Family Applications (2)

Application Number Title Priority Date Filing Date
EP08845600.9A Not-in-force EP2219603B1 (en) 2007-11-02 2008-10-31 Transdermal delivery system
EP08845547.2A Not-in-force EP2214643B1 (en) 2007-11-02 2008-10-31 Transdermal delivery system for hormones and steroids

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP08845600.9A Not-in-force EP2219603B1 (en) 2007-11-02 2008-10-31 Transdermal delivery system

Country Status (18)

Country Link
US (5) US20100279988A1 (en)
EP (2) EP2219603B1 (en)
JP (2) JP2011502172A (en)
KR (2) KR20100094495A (en)
CN (2) CN101888830B (en)
AU (2) AU2008318284B2 (en)
BR (2) BRPI0819245A2 (en)
CA (2) CA2704117C (en)
DK (2) DK2219603T3 (en)
EA (2) EA019760B1 (en)
ES (2) ES2494853T3 (en)
HK (2) HK1143091A1 (en)
MX (2) MX2010004788A (en)
NZ (2) NZ585034A (en)
PL (2) PL2214643T3 (en)
PT (2) PT2219603E (en)
WO (2) WO2009055860A1 (en)
ZA (1) ZA201003553B (en)

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US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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US10449201B2 (en) * 2015-08-17 2019-10-22 Alpha To Omega Pharmaceutical Consultants, Inc. Transdermal and/or topical delivery system comprising clobazam
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WO2017173071A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
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KR102436756B1 (en) * 2017-01-31 2022-08-29 신신제약 주식회사 A transdermal drug delivery system containing a non-steroidal anti-inflammatory analgesic and salicylic acid derivatives
CN107929268A (en) * 2017-12-19 2018-04-20 郑州泰丰制药有限公司 A kind of transdermal patch of the medicine containing proton pump inhibitor and preparation method thereof
EP3737374B1 (en) * 2018-01-10 2024-04-03 Celista Pharmaceuticals Llc Testosterone transdermal spray with film
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AU2008318284A1 (en) 2009-05-07
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EA201000746A1 (en) 2010-10-29
US20130317122A1 (en) 2013-11-28
US9078810B2 (en) 2015-07-14
CN101883556B (en) 2013-05-29
US20160022820A1 (en) 2016-01-28
PL2214643T3 (en) 2014-09-30
CA2704116A1 (en) 2009-05-07
JP2011502173A (en) 2011-01-20
EA019760B1 (en) 2014-06-30
EP2219603A4 (en) 2010-11-17
BRPI0819245A2 (en) 2016-07-19
HK1144375A1 (en) 2011-02-18
CN101888830A (en) 2010-11-17
DK2214643T3 (en) 2014-05-26
HK1143091A1 (en) 2011-03-18
KR101662186B1 (en) 2016-10-04
US20100279988A1 (en) 2010-11-04
MX2010004789A (en) 2010-07-05
CA2704117C (en) 2015-11-17
KR20100094495A (en) 2010-08-26
CA2704117A1 (en) 2009-05-07
EA201000747A1 (en) 2010-10-29
EP2219603B1 (en) 2014-07-16
JP5737942B2 (en) 2015-06-17
WO2009055860A1 (en) 2009-05-07
EP2214643B1 (en) 2014-04-02
PL2219603T3 (en) 2014-10-31
JP2011502172A (en) 2011-01-20
WO2009055859A1 (en) 2009-05-07
NZ585033A (en) 2011-12-22
CN101888830B (en) 2013-01-23
PT2214643E (en) 2014-05-26
US20100297032A1 (en) 2010-11-25
DK2219603T3 (en) 2014-09-01
BRPI0819235A2 (en) 2017-08-22
MX2010004788A (en) 2010-09-14
EP2219603A1 (en) 2010-08-25
ES2466676T3 (en) 2014-06-10
US20130317462A1 (en) 2013-11-28
ES2494853T3 (en) 2014-09-16
AU2008318283B2 (en) 2012-03-29
CN101883556A (en) 2010-11-10
AU2008318284B2 (en) 2012-03-22
NZ585034A (en) 2011-08-26
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ZA201003553B (en) 2011-02-23
EP2214643A1 (en) 2010-08-11

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